CompletedNot Applicable

Longitudinal Protocol for Granulomatosis With Polyangiitis (Wegener's) and Microscopic Polyangiitis

United States1,046 participantsStarted 2006-04

Plain-language summary

Granulomatosis with polyangiitis (Wegener's) (GPA) and microscopic polyangiitis (MPA) are two rare immune system disorders that cause the inflammation of blood vessels, or vasculitis. In order to properly treat these diseases, it is critical that the level of disease activity can be determined over the course of the disease. The purpose of this study is to determine new biological markers, or biomarkers, that may be used to assess the severity of disease in people with GPA or MPA.

Who can participate

SexALL

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Inclusion criteria

✓. Nasal or oral inflammation with oral ulcers or nasal discharge with pus or blood
✓. Abnormal chest radiograph with nodules, fixed infiltrates, or cavities
✓. Urinary sediment with microhematuria or red cell casts
✓. Granulomatous inflammation within the wall of an artery or in the perivascular area on biopsy
✓. Antineutrophil cytoplasmic antibody (ANCA) positive by enzyme immunoassay for either PR3- or MPO-ANCA
✓. Necrotizing vasculitis, with few or no immune deposits, that affects small vessels (i.e., capillaries, venules, arterioles)
✓. Necrotizing arteritis involving small- and medium-sized arteries may be present
✓. Necrotizing glomerulonephritis is very common

What they're measuring

Discover biomarkers in GPA/MPA capable of measuring disease activity and response to treatment.

Timeframe: Study completion

Trial details

NCT IDNCT00315393

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-12

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